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Clinical Trial Protocol
PROTOCOL Dok.#: 129K-PMS-MR Page 1 of 55 Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children Phase IV PMS-MR-0417 CLINICAL TRIAL PROTOCOL Sponsor PT BIO FARMA (PERSERO) Jl. Pasteur No. 28 Bandung – 40161 Indonesia August 2017 The information contained in this document is the property of Bio Farma and is confidential. It may be submitted to a Regulatory Authority, an Institutional Review Board/Ethics Committee, or an Investigator or a Pharmacist for the purpose of assessment in relation to registration of the product or initiation of a clinical trial. Reproduction or disclosure of the information in whole or in part is forbidden without the written consent of Bio Farma. This document must be returned to Bio Farma Versionupon request. 1.0 August 2017 PT Bio Farma PROTOCOL Dok.#: 129K-PMS-MR Page 2 of 55 Reactogenicity and Protectivity Following Measles-Rubella (MR) Routine Immunization in Indonesian Infants and Children PMS-MR-0417 CLINICAL TRIAL PHASE IV (POST MARKETING SURVEILLANCE) Sponsor PT. BIO FARMA (PERSERO) Jl. Pasteur No. 28 Bandung – 40161 INDONESIA Investigational Product Measles-Rubella (MR) Vaccine Manufacturing Sites Serum Institute of India PVT.LTD. 212/2, Hadapsar, Pune 411028, India Principal Investigator Dr. dr. Dominicus Husada, SpA(K) Sub-Investigators dr. Dwiyanti Puspitasari, SpA(K) dr. Leny Kartina, SpA(K) Medical Advisor Prof. Dr.dr. Ismoedijanto, SpA(K) Prof. dr. Parwati S. Basuki, SpA(K) Biometry Dr. dr. Windhu Purnomo, MS Monitors Dr. Novilia Sjafri Bachtiar, dr., M.Kes. Rini Mulia Sari, dr. Julianita Fahmi, dr. Asep Irham Fattahul Qur'an, dr Biological Laboratory Rini Mulia Sari, dr. -
Trends in Vaccine Development
ADVERTISEMENT FEATURE NATUREJOBS SPOTLIGHT ON VACCINES Trends in vaccine development How are public-private partnerships, low-cost manufacturers and new technology afecting the vaccine field? “The vaccine field BILL GATES is a handy person to grow over the next few years. the virus was identifed in 1984, to have in your corner, which In the United States, demand researchers were optimistic they is going to enlarge bodes well for those committed to will increase by around 7 percent could formulate a vaccine quickly. vaccine research. In January 2010 annually until 2015, according to a As HIV proved resilient, hopes for substantially beyond the philanthropist called for a 2011 report published by industry a fast response faded and by the SPOTLIGHT ON IMMUNOLOGY / VACCINES ON IMMUNOLOGY SPOTLIGHT “decade of vaccines” and pledged analysts Freedonia. “It’s probably early 1990s several research groups the traditional US$10 billion for vaccine research the best growth area right now in and companies had abandoned and development (R&D) and infectious disease,” says Steve Projan, the search for a vaccine. preventive vaccine.” distribution. Te Bill & Melinda senior vice president of R&D in It became clear that a new Gates Foundation funding will the innovative medicines unit at model of vaccine development was Rafi Ahmed, Emory Vaccine Center boost an already burgeoning feld. vaccine manufacturer MedImmune. needed, one that could bridge the Although vaccines comprise Te industry is being shaped by gap between the public and private a small portion of the global increased collaboration between the sectors and focus on the developing pharmaceutical market — 2 percent public and private sectors, the rise world. -
1C 173/49 Importer / Manufacturer: Biogenetech Co., Ltd. / PT. Bio
Registration No.: 1C 173/49 Importer / Manufacturer: Biogenetech Co., Ltd. / PT. Bio Farma SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL PRODUCT Measles Vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition Dose Volume 0.5 ml Measles Virus strain CAM 70 not less than 1000 CCID50 Kanamycin sulphate not more than 100 μgm Erythromycin not more than 30 μgm Diluent Water for injection (WFI) 3. PHARMACEUTICAL FORM It is a live, attenuated virus vaccine. Each dose contains not less than 1,000 CCID50 (cell culture infective doses 50%) of Measles virus strain CAM 70, prepared in SPF chicken embryo and not more than 100 mcg of kanamycin sulphate and 30 mcg of erythromycin. This vaccine is a freeze- dried product that must be reconstituted only with the sterile diluent provided separately for that purpose. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Prophylactic immunization against Measle. 4.2 Posology and method of administration Immunization schedule In countries where the incidence and mortality from measles is high in the first year of life, the recommended age for vaccination against measles is at 9 months of age (270 days) or shortly after. Incountries where infection occurs later in life (due to sustained high vaccination coverage), the age of vaccination can be moved to 12-15 months. It is recommended that all children have two (2) opportunities for measles immunization to reduce the number both of unvaccinated children and of those who are vaccinated but fail to respond to the vaccine (primary vaccination failure). Although generally administered at school entry (4-6 years of age), the second opportunity for measles immunization may be provided as early as one (1) month following the first dost through routine or supplemental immunization activities. -
PDF: 300 Pages, 5.2 MB
The Bay Area Council Economic Institute wishes to thank the sponsors of this report, whose support was critical to its production: The Economic Institute also wishes to acknowledge the valuable project support provided in India by: The Bay Area Council Economic Institute wishes to thank the sponsors of this report, whose support was critical to its production: The Economic Institute also wishes to acknowledge the valuable project support provided in India by: Global Reach Emerging Ties Between the San Francisco Bay Area and India A Bay Area Council Economic Institute Report by R. Sean Randolph President & CEO Bay Area Council Economic Institute and Niels Erich Global Business/Transportation Consulting November 2009 Bay Area Council Economic Institute 201 California Street, Suite 1450 San Francisco, CA 94111 (415) 981-7117 (415) 981-6408 Fax [email protected] www.bayareaeconomy.org Rangoli Designs Note The geometric drawings used in the pages of this report, as decorations at the beginnings of paragraphs and repeated in side panels, are grayscale examples of rangoli, an Indian folk art. Traditional rangoli designs are often created on the ground in front of the entrances to homes, using finely ground powders in vivid colors. This ancient art form is believed to have originated from the Indian state of Maharashtra, and it is known by different names, such as kolam or aripana, in other states. Rangoli de- signs are considered to be symbols of good luck and welcome, and are created, usually by women, for special occasions such as festivals (espe- cially Diwali), marriages, and birth ceremonies. Cover Note The cover photo collage depicts the view through a “doorway” defined by the section of a carved doorframe from a Hindu temple that appears on the left. -
Dentons Flashpoint Daily Global Situation Report
Dentons Flashpoint Daily Global Situation Report December 14, 2020 Global Situation Update: December 14, 2020 KEY TAKEAWAYS The US orders First COVID-19 emergency action The UN calls on vaccines to be after huge cyber every country administered in the security breach to declare a US and Canada involving the “climate emergency.” today. SolarWinds’ Orion platform. Note: This report is based on sources and information deemed to be true and reliable, but Dentons makes no representations to same. Global Globally, confirmed coronavirus cases surpassed 72 million infections and 1.6 million deaths. • Secretary-General Guterres called on every • German biotech firm CureVac has enrolled the country to declare a “climate emergency” as first participant for a Phase 2b/3 clinical trial world leaders marking the fifth anniversary of of its COVID-19 vaccine candidate, expected the Paris climate accord made mostly to include more than 35,000 participants in incremental pledges relative to the scale of the Europe and Latin America. crisis. • Peru suspended clinical trials of a Chinese Sinopharm Covid-19 vaccine after one of the volunteers involved in the program suffered a “serious adverse event”. Note: This report is based on sources and information deemed to be true and reliable, but Dentons makes no representations to same. Global Over the past week, the global curve for new cases continued to flatten, while topping 72 million. One week ago, the count was 67 million. The US continues to be the global leader for new infections, reporting more than 200,000 new cases for most of last week. Turkey has become the new global hotspot, with new cases doubling in eight days to over 1.8 million. -
Panacea Biotec Receives $24.32M Award from UN Agencies
Panacea Biotec receives $24.32M award from UN Agencies 23 December 2019 | News | By Manbeena Chawla Easyfive-TT (DTwP-HepB-Hib) was introduced by Panacea Biotec as world’s first fully liquid wP-based pentavalent vaccine in Indian market in 2005. New Delhi based biotechnology company Panacea Biotec has received Awards worth USD 24.32 Million (Over Rs.170 crores) from U.N. Agencies (UNICEF and PAHO) for supply of its Easyfive-TT, a fully liquid WHO prequalified Pentavalent Vaccine. UNICEF award is for year 2020 and award of PAHO is for three (3) years i.e. 2020-2022. Pediatric vaccination plays an important role to achieve Sustainable Development Goals set by the United Nations, in particular the target to reduce under-five mortality rate to less than 25 per 1000 live births. Pentavalent vaccine protects children against five deadly diseases; Diphtheria, Tetanus, Pertussis, Hepatitis B and invasive infections caused by Haemophilus Influenza Type b – becoming the foundation of paediatric immunization programs across the world. Easyfive-TT (DTwP-HepB-Hib) was introduced by Panacea Biotec as world’s first fully liquid wP-based pentavalent vaccine in Indian market in 2005. With WHO prequalification in 2008, over 100 million doses have been supplied to more than 50 countries globally. Easyfive-TT is ready for use without further preparation by healthcare workers in the field, which offers major healthcare advantages in countries with challenging infrastructure and hygiene problems. Panacea Biotec has contributed significantly for Children’s Health and has partnered with WHO, UNICEF & PAHO in their efforts to maximize coverage of vaccines under the Expanded Program on Immunization (EPI) in developing countries. -
Responsive COVID-19 Vaccines for Recovery Project Under the Asia Pacific Vaccine Access Facility (Guaranteed by the Republic of Indonesia)
Report and Recommendation of the President to the Board of Directors Project Number: 54425-001 March 2021 Proposed Loan PT Bio Farma (Persero) Responsive COVID-19 Vaccines for Recovery Project under the Asia Pacific Vaccine Access Facility (Guaranteed by the Republic of Indonesia) Distribution of this document is restricted until it has been approved by the Board of Directors. Following such approval, ADB will disclose the document to the public in accordance with ADB’s Access to Information Policy. CURRENCY EQUIVALENTS (as of 5 March 2021) Currency unit – rupiah (Rp) Rp1.00 = $0.0000697 $1.00 = Rp14,349 ABBREVIATIONS ADB – Asian Development Bank AEFI – adverse event following immunization APVAX – Asia Pacific Vaccine Access Facility Bio Farma – PT Bio Farma (Persero) COVID-19 – coronavirus disease Indofarma – PT Indofarma Tbk LIBOR – London interbank offered rate M&E – monitoring and evaluation MOH – Ministry of Health PAM – project administration manual RRC – rapid response component TA – technical assistance UNICEF – United Nations Children’s Fund VAP – Vaccination Allocation Plan VIRAT – Vaccination Introduction Readiness Assessment Tool WHO – World Health Organization NOTE In this report, “$” refers to United States dollars. Vice-President Ahmed M. Saeed, Operations 2 Director General Ramesh Subramaniam, Southeast Asia Department (SERD) Directors Ayako Inagaki, Human and Social Development Division (SEHS), SERD Winfried Wicklein, Country Director, Indonesia Resident Mission (IRM), SERD Said Zaidansyah, Deputy Country Director, IRM, -
Manufacturing Permission of Human Vaccines Year 2021
Manufacturing Permission of Human Vaccines Year 2021 S. No. Name of Firm Name of Molecule Indication Date Approved 1 M/s Serum Institute ChAdOx1 nCoV-19 For Restricted use in emergency Permission No. of India Pvt. Ltd. Corona Virus Vaccine situation: MF/BIO/21/000001 dated 212/2, Off. Soli (Recombinant) For active immunization of 03.01.2021 Poonawalla Road, individuals of ≥18 years old for the Hadapsar Pune, prevention of corona virus disease Maharashtra, India. (COVID-19) when administered in two doses schedule. The second dose should be administered between 4 to 6 weeks after the first dose. However, there is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies. 2 M/s Bharat Biotech Whole Virion Inactivated For Restricted use in emergency Permission No. International Corona Virus Vaccine, situation in clinical trial mode: MF/BIO/21/000002 dated Limited, Sy. No. [BBV152] For active immunization against 03.01.2021 230, 231 & 235, Corona Virus Disease (COVID-19) Genome Valley, for age ≥12 years when Shameerpet administered in two doses interval Mandal, Medchal- of day 0 & day 28. Malkajgiri District, Telangana-500078, India. Manufacturing Permission of Human Vaccines Year 2020 S. No. Name of Firm Name of Molecule Indication Date Approved 1 M/s Biological E. Typhoid Vi Conjugate For active immunization against MF/BIO/20/000001 dated Limited, Plot No. 1, Vaccine, IP infection caused by Salmonella 28.01.2020 Phase II, Biotech typhi in infants, children, Park, Kolthur adolescents and adults aged ≥ 6 Village, Shameerpet months to ≤ 45 years. -
Annual Report 17-18 Initial Pages for Web.Cdr
Contents Safe Harbour Statement Corporate Information 01 This report contains forward-looking statements, which may be identied by their use of words like Tribute to Late Shri Ravinder Jain 02 ‘plans’, ‘expects’, ‘will’, ‘anticipates’, ‘believes’, Vision, Mission & Values 03 ‘intends’, ‘projects’, ‘estimates’, or other words of similar meaning. All statements that address Chairman's Message 04 expectations or projections about the future, Panacea Biotec at a Glance 06 including but not limited to statements about Company’s future growth drivers, product Financial Highlights 07 development, market position and expenditures Core Strengths 08 are forward looking statements. Forward looking statements are based on certain assumptions and Management Discussion & Analysis 10 expectations for future events. The Company may Directors' Report 25 not guarantee that these assumptions and expectations are accurate and will be realised. The Corporate Governance Report 49 Company’s actual results, performance or Auditors' Report on Standalone achievements could thus differ materially from Financial Statements 66 those projected in any forward-looking Standalone Financial Statements 72 s t ate m e nt s. Th e Co m p a ny a s s u m e s n o responsibility to publicly amend, modify, revise Auditors' Report on Consolidated any forward-looking statements, on the basis of Financial Statements 106 any subsequent developments, information and Consolidated Financial Statements 110 events. Mr. Soshil Kumar Jain, Chairman (Sitting) along with his colleagues on the Board and other officials (from left) Mr. Mahipat Singh, Mr. Vinod Goel, Mr. N. N. Khamitkar, Mr. O. P. Kelkar, Mr. Mukul Gupta, Mr. K. M. Lal, Dr. -
Could Vaccine Dose Stretching Reduce Covid-19 Deaths?
NBER WORKING PAPER SERIES COULD VACCINE DOSE STRETCHING REDUCE COVID-19 DEATHS? Witold Więcek Amrita Ahuja Michael Kremer Alexandre Simoes Gomes Christopher Snyder Alex Tabarrok Brandon Joel Tan Working Paper 29018 http://www.nber.org/papers/w29018 NATIONAL BUREAU OF ECONOMIC RESEARCH 1050 Massachusetts Avenue Cambridge, MA 02138 July 2021 The authors are grateful to Nora Szech, Ezekiel Emanuel, Marc Lipsitch, Prashant Yadav, Patrick Smith, Frédéric Y. Bois, Virginia Schmit, Victor Dzau, Valmik Ahuja, Marcella Alsan, Garth Strohbehn and seminar participants at Harvard, M.I.T., the University of Chicago, and the NBER Entrepreneurship and Innovation Policy and the Economy conference for helpful comments and to Esha Chaudhuri for excellent research assistance. This work was supported in part by the Wellspring Philanthropic Fund (Grant No: 15104) and Open Philanthropy. The views expressed herein are those of the authors and do not necessarily reflect the views of the National Bureau of Economic Research. NBER working papers are circulated for discussion and comment purposes. They have not been peer-reviewed or been subject to the review by the NBER Board of Directors that accompanies official NBER publications. © 2021 by Witold Więcek, Amrita Ahuja, Michael Kremer, Alexandre Simoes Gomes, Christopher Snyder, Alex Tabarrok, and Brandon Joel Tan. All rights reserved. Short sections of text, not to exceed two paragraphs, may be quoted without explicit permission provided that full credit, including © notice, is given to the source. Could Vaccine Dose Stretching Reduce COVID-19 Deaths? Witold Więcek, Amrita Ahuja, Michael Kremer, Alexandre Simoes Gomes, Christopher Snyder, Alex Tabarrok, and Brandon Joel Tan NBER Working Paper No. -
Julie Miloud Kaddar Vaccine 2
This article appeared in a journal published by Elsevier. The attached copy is furnished to the author for internal non-commercial research and education use, including for instruction at the authors institution and sharing with colleagues. Other uses, including reproduction and distribution, or selling or licensing copies, or posting to personal, institutional or third party websites are prohibited. In most cases authors are permitted to post their version of the article (e.g. in Word or Tex form) to their personal website or institutional repository. Authors requiring further information regarding Elsevier’s archiving and manuscript policies are encouraged to visit: http://www.elsevier.com/copyright Author's personal copy Vaccine 28 (2010) 2115–2121 Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine The role of emerging manufacturers in access to innovative vaccines of public health importanceଝ Julie B. Milstien a,∗, Miloud Kaddar b a University of Maryland School of Medicine, Geographic Medicine, 685 West Baltimore Street, Baltimore, MD 21201-1509, United States b Department of Immunization, Vaccines and Biologicals, World Health Organization, 1211 Geneva 27, Switzerland article info abstract Article history: The role of developing country manufacturers in assuring global access to innovative vaccines was com- Received 13 December 2009 pared to the situation in 2005. These producers now supply over 60% of traditional vaccines doses globally Accepted 14 December 2009 and an increasing value (up to 15% in 2007) of innovative products. More suppliers are now strong play- Available online 29 December 2009 ers in global market, and an even larger group has potential to do so. -
Vaccination and Multiple Sclerosis in the Era of the COVID-19 Pandemic
J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp-2021-326839 on 5 August 2021. Downloaded from Occasional essay Vaccination and multiple sclerosis in the era of the COVID-19 pandemic Tobias Monschein ,1 Hans- Peter Hartung,1,2 Tobias Zrzavy ,1 Michael Barnett ,3 Nina Boxberger,4 Thomas Berger,1 Jeremy Chataway,5 Amit Bar- Or,6 Paulus Stefan Rommer ,1,4 Uwe K. Zettl4 24 ► Additional supplemental INTRODUCTION higher binding affinity. On entering the respira- material is published online In the last century, several pandemics were caused tory epithelial cells, SARS-CoV -2 starts replicating only. To view, please visit by various influenza virus subtypes, with the Spanish and spreading rapidly until it reaches the alveolar the journal online (http:// dx. 1 doi. org/ 10. 1136/ jnnp- 2021- influenza of 1918–1920 being the most severe. epithelial cells of the lung. Hence, a robust innate 326839). Coronaviruses were first described in humans in immune response is triggered.25 The spike protein the 1960s, and since then seven human pathogenic is recognised by pattern recognition receptors For numbered affiliations see coronaviruses have been described.2 The first severe and leads, via downstream signalling, to increased end of article. outbreak was in 2002 with the severe acute respira- interferon production by innate immune cells. Antigen- specific adaptive immunity is critical for Correspondence to tory syndrome coronavirus (SARS- CoV), followed Dr Tobias Monschein, by the Middle East respiratory syndrome corona- the immune response to SARS- CoV-2 infection. Department of Neurology, virus (MERS- CoV) outbreak in 2012.3 The current Both CD8 and CD4 T cells are activated via their Medical University of Vienna, COVID-19 pandemic, which broke out in Wuhan, respective major histocompatibility complexes I or Vienna, Austria; tobias.